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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 1076

Kuraray Company, Ltd.

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

Food Contact Substance: Ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers modified with up to 8 mol% 1,2-epoxypropane (CAS Reg. No. 482589-30-0).
Notifier: Kuraray Company, Ltd.
Manufacturer: Kuraray Company, Ltd.
Intended Use: As an internal, non food-contact layer separated from food by one or more layers having a suitable regulatory status for use in direct contact with food in single service and repeated-use food-contact articles both (1) as a stand-alone layer; or (2) at levels of up to 30% in blends with EVOH.
Limitations/Specifications*: 1. The maximum thickness of the internal layer when the FCS is used alone will be 50 μm. The finished food-contact articles may be used in contact with Food Types I, II, III, IVA, IVB, V, VIA, VIB, VIC (up to 15 percent alcohol), VIIA, VIIB, VIII, and IX under Conditions of Use B through H as defined in Tables 1 and 2.
2. The maximum thickness of the internal layer when the FCS is used in blends with EVOH will be determined by the relationship: (50 μm)/(x), where "x" is the fraction of the FCS in the blend. The finished food-contact articles may be used in contact with Food Types I, II, III, IVA, IVB, V, VIA, VIB, VIC (up to 15 percent alcohol), VIIA, VIIB, VIII, and IX under Conditions of Use B through H as defined in Tables 1 and 2.
Effective Date: Jun 23, 2011
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (740 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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